KIDScore D3
Vitrolife A/SKIDScore D3 is an AI-based decision support tool designed to aid embryologists in assessing the viability of embryos on Day 3 by scoring their likelihood to develop to the blastocyst stage. It integrates with the EmbryoScope timelapse incubator systems and helps clinicians select embryos for transfer, freezing, or continued development, enhancing decision-making in assisted reproduction procedures.
Intended Use
The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability. Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
Technology
KIDScore D3 is a software decision support tool integrated with EmbryoViewer software on the EmbryoScope system. It relies on manual annotations of embryo morphokinetic parameters (cell division timings and pronuclei observations) to classify embryos into score groups (0-5). The classification model uses elimination criteria based on developmental timings and cell counts to predict embryo viability. Calculations are performed on the ES Server software connected to the incubators.
Performance
Performance testing included software verification and validation per FDA guidance, algorithm reproducibility, and a prospective, multicenter clinical study with 81 patients' embryo data assessing prediction accuracy against blastocyst development outcomes. Results demonstrated that KIDScore D3 adjunctively improved embryo selection over morphology alone, with statistically significant odds ratios exceeding 4. Clinical data confirmed safety and effectiveness in predicting embryo development.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/2/2018
9 months - 2
FDA Approval
7/19/2019
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